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Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00987727
Recruitment Status : Completed
First Posted : October 1, 2009
Results First Posted : September 21, 2011
Last Update Posted : September 21, 2011
Sponsor:
Information provided by:
Allergan

Tracking Information
First Submitted Date  ICMJE September 29, 2009
First Posted Date  ICMJE October 1, 2009
Results First Submitted Date  ICMJE August 17, 2011
Results First Posted Date  ICMJE September 21, 2011
Last Update Posted Date September 21, 2011
Study Start Date  ICMJE November 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2011)
Change From Baseline in Global Ocular Staining Score at Day 35 [ Time Frame: Baseline, Day 35 ]
Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst).
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2009)
Global Ocular Staining [ Time Frame: Day 35 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2011)
Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35 [ Time Frame: Baseline, Day 35 ]
Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2009)
OSDI score [ Time Frame: Day 35 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
Official Title  ICMJE Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
Brief Summary This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Dry Eye Syndromes
  • Keratoconjunctivitis Sicca
Intervention  ICMJE
  • Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
    One drop in each eye three to six times daily, as needed
    Other Name: OPTIVE® MD
  • Drug: sodium hyaluronate 0.18% (VISMED® Multi)
    One drop in each eye three to six times daily, as needed
    Other Name: VISMED® Multi
Study Arms  ICMJE
  • Experimental: 1
    carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
    Intervention: Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
  • Active Comparator: 2
    sodium hyaluronate 0.18% (VISMED® Multi)
    Intervention: Drug: sodium hyaluronate 0.18% (VISMED® Multi)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2011)
82
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2009)
80
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have been using artificial tears for at least 3 months prior to study inclusion
  • Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion
  • Having moderate to severe symptoms suggestive of dry eye

Exclusion Criteria:

  • Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study
  • Moderate to severe blepharitis
  • History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months
  • History or active signs of ocular allergic disease or ocular herpes within the last year
  • History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00987727
Other Study ID Numbers  ICMJE MAF-AGN-OPH-DE-011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vice President Medical Affairs, Allergan, Inc.
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP